# FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office (manufacturer, HANAMAKI-SHI Iwate, JP): 10 new FDA device listings, incl. gastrointesinal lesion software detection system

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office |
| Owner / operator | Fujifilm Corporation |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | HANAMAKI-SHI Iwate, JP |
| New listings | 10 |
| Devices | Gastrointesinal Lesion Software Detection System; System, Image Processing, Radiological; Automated Radiological Image Processing Software; Led Light Source; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscopic Light-Projecting Measuring Device; Endoscope, Accessories, Image Post-Processing For Color Enhancement; Colonoscope And Accessories, Flexible/Rigid; Enteroscope And Accessories; Endoscope, Accessories, Narrow Band Spectrum |
| Product codes | QNP, LLZ, QIH, NTN, FET, QTH, PEA, FDF, FDA, NWB |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Radiology |
| Brand names | EW10-EC02; Synapse 3D Base Tools (V7.2); EP-8000; EW10-VM01; PB-30 |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-08-28 |
| FDA registration number | 3003775006 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.